BACKGROUND AND AIMS Standardized definitions for outcome measures in randomized clinical trials and observational studies are essential for robust and valid evaluation of medical products, interventions, care, and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology aimed to create international data standards for cardiovascular clinical study outcome measures. METHODS The EuroHeart methods for data standard development were used. From a Global Cardiovascular Outcomes Consortium of 82 experts, five Working Groups were formed to identify and define key outcome measures for: cardiovascular disease (generic outcomes), acute coronary syndrome and percutaneous coronary intervention (ACS/PCI), atrial fibrillation (AF), heart failure (HF) and transcatheter aortic valve implantation (TAVI). A systematic review of the literature informed a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition and categorized the variable as mandatory (Level 1) or optional (Level 2) based on its clinical importance and feasibility. RESULTS Across the five domains, 24 Level 1 (generic: 5, ACS/PCI: 8, AF: 2; HF: 5, TAVI: 4) and 48 Level 2 (generic: 18, ACS-PCI: 7, AF: 6, HF: 2, TAVI: 15) outcome measures were defined. CONCLUSIONS Internationally derived and endorsed definitions for outcome measures for a range of common cardiovascular diseases and interventions are presented. These may be used for data alignment to enable high-quality observational and randomized clinical research, audit, and quality improvement for patient benefit.

中文翻译：

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心血管疾病临床研究结果测量的定义：欧洲心脏护理评估和随机试验统一登记处 （EuroHeart）。


背景和目的 随机临床试验和观察性研究中结果测量的标准化定义对于对医疗产品、干预措施、护理和结果的稳健和有效评估至关重要。欧洲心脏病学会的欧洲心脏护理评估和随机试验联合登记库 （EuroHeart） 项目旨在为心血管临床研究结果测量创建国际数据标准。方法 使用 EuroHeart 方法进行数据标准开发。由 82 名专家组成的全球心血管结果联盟成立了 5 个工作组，以确定和定义以下关键结果指标：心血管疾病（一般结果）、急性冠脉综合征和经皮冠状动脉介入治疗 （ACS/PCI）、心房颤动 （AF）、心力衰竭 （HF） 和经导管主动脉瓣植入术 （TAVI）。对文献的系统评价为一种改进的 Delphi 方法提供了信息，以就最终的变量集达成共识。对于每个变量，工作组提供了一个定义，并根据其临床重要性和可行性将变量分类为强制性（1 级）或可选（2 级）。结果 在五个领域中，24 个 1 级（通用：5，ACS/PCI：8，AF：2;定义了 HF：5，TAVI：4）和 48 2 级（通用：18，ACS-PCI：7，AF：6，HF：2，TAVI：15）结果测量。结论 提出了一系列常见心血管疾病和干预措施的结果测量的国际衍生和认可的定义。这些可用于数据对齐，以实现高质量的观察性和随机临床研究、审计和质量改进，从而使患者受益。